Past Discussions
International Health IT News
This site presents a selection of news items collected from over 150 Health IT news and blog sites. The contents of this site is updated hourly
links for 2010-03-19
Read more [FutureHIT]
EMR/EHR vs. PHR, ad nauseam
Mainstream media still don't get it. Personal health records and electronic health records/electronic medical records are not the same thing. Yet, on the agenda for next month's annual Association of Health Care Journalists conference is a panel entitled "Personal electronic medical records: What will consumers need to know?"
The meeting is here in Chicago next month, but I already have plans to be out of town. I'm debating whether to change those plans to attend this meeting, because there are some sessions that could be of value to me. I may want to go just to be a voice for reporting on health IT. The lack of focus on health IT was what made me quit AHCJ four years ago.
Every time I see the phrase, "electronic personal health records," my blood boils. Last time was this Dec. 2, 2009, article in something called eSecurity Planet that erroneously said the federal stimulus was paying for "electronic personal health records." I used this story as an example for a yet-to-be published piece I've written for Reporting on Health, a project of the USC Annenberg School and California Endowment Health Journalism Fellowship.
For the record, I define an EHR as, at least in theory, a comprehensive digital collection of information about an individual’s health and medical status that encompasses multiple care settings. EMR means a record tied to a single facility or organization. The two phrases often are used interchangeably, and I think that's OK for now.
A PHR, to me, is a record that patients can view, update and control access to. It is a subset of an EHR, not a synonym.
Read more [Neil Versel's Healthcare IT Blog]
BrainLab Takes iPhone-like Digital Lightbox to Next Logical Step
We have previously mentioned that BrainLab's Digital Lightbox reminds us of a giant iPhone. Clearly agreeing with our way of thinking, last week at the American Academy of Orthopedic Surgeons we saw BrainLab demonstrate an implementation of their knee navigation software that simply uses an iPhone/iPod Touch, coupled with a passive tracking attachment and iPhone App. The iPhone, with attached markers, is used to identify bony landmarks on the knee, which are then fed into the BrainLab software for 3-D guidance of knee surgery. The iPhone screen is used as the display, both for marker placement prompting and leg-alignment indicators during the procedure. Using the motion tracking sensor and the iPhone as an input and display, rather than the other solutions BrainLab supports (shown below), reduces the footprint needed in the OR. There is no mention of the iPhone version of their imaging suite on the BrainLab website, but the FDA 510(K) clearance given for its Uni-Knee software does not define the display technology used, seemingly allowing this configuration. uni-knee product page... FDA 510K Summary......
Michael
Read more [Medgadget]
Webinar on Certification Programs for HIT NPRM March 25, 2010 4:00 – 5:00 p.m. EDT
This came from the nice folks at ONC this morning: On March 25, 2010 from 4:00 – 5:00 p.m. EDT, The Office of the National Coordinator for Health Information Technology (ONC), with the National Institute of Standards and Technology (NIST), will present a webinar on the recently released Certification Programs for HIT Notice of Proposed Rulemaking (NPRM). Public comments on the NPRM are now being accepted. The temporary certification program’s comment period ends April 9 and the permanent certification program’s comment period ends May 10. Because this NPRM is currently in the comment period phase, this webinar will be solely informational and seeks to help listeners better understand the proposals included in the NPRM. Background Learn more about the NPRM at http://healthit.hhs.gov/CertificationNPRM To Participate Join the meeting (click this on the 25th before 4:00 PM) Audio Information First Time Users: Troubleshooting
Eligible professionals and eligible hospitals who seek to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs are required by statute to use Certified EHR Technology. This webinar will discuss the proposals included in the NPRM that would enable eligible professionals and eligible hospitals to adopt health IT that meets the definition of Certified EHR Technology.
There is limited space on this webinar. For those unable to join, there will be a transcript posted to the ONC website, http://healthit.hhs.gov, by March 29, 2010.
Dial-In: 1-888-673-9805
Participant Passcode: 9033671
To save time before the meeting, check your system to make sure it is ready to use Microsoft Office Live Meeting.
Unable to join the meeting? Follow these steps:
Read more [The Healthcare IT Guy]
Hitachi Offers Its Own Take on Ultrasound Elastography
Major ultrasound companies Siemens, GE, and Philips have all offered differing flavors of ultrasound elastography, and now Hitachi has entered the market with Hitachi Real-Time Tissue Elastography (HiRTE). Elastography is a technology that uses ultrasound to tell clinicians about the relative tissue hardness, approved in Europe for identifying firmer, possibly cancerous, regions of soft tissues such as liver, breast, and prostate. It uses the visualization of the propagation of mechanical waves through the tissue to derive either a shear wave velocity or a Young's modulus as a measure of tissues stiffness. Hitachi's claim about the measurement being real-time is in comparison to other providers of elastography which require post-processing of static images either at another workstation or after the image is taken. The Hitachi application will be part of its compact platform Hi Vision Avius. From Diagnostic Imaging: Hitachi Medical Systems has been a pioneer in the clinical development of elastography and is offering its own version of this technology, Hitachi Real-Time Tissue Elastography (HiRTE), as a key application on its new compact ultrasound platform, Hi Vision Avius, which follows last year's launch of the Hi Vision Preirus. The application is part of a package of advanced product features on the new machine, including established technologies such as Hi Rez+ (tissue adaptive filtering), HdTHI (high-definition dynamic tissue harmonic imaging) and Hi Com (frequency and spatial compounding), as well as new features such as RVS (real-time virtual sonography). The latter is a software application that uses magnetic tracking sensors on the ultrasound transducer to display real-time freehand ultrasound images alongside synchronous other images. Elastography may also have applications in cases of rectal cancer. More from Diagnostic Imaging: Elastography advances feature prominently among ultrasound exhibits... Product page: Hitachi Real-time Tissue Elastography (HI-RTE)...
Michael
Read more [Medgadget]
Sneak Preview of Dr Nano X Game for iPhone
Mission Critical Studios, makers of DR Nano iPhone game that we covered previously, is about to release the next version of the nanomedicine inspired video game. Here's what a company rep tells us about the new version: Dr Nano was basically a tunnel game in one environment. We took a different approach when creating Dr Nano X we treated as though we were creating a console game. Dr Nano X has new characters, new worlds to explore in the Nano Verse on foot, sub and swimming. New weapons... even a jetpack. Dr Nano X is all about the mission. Using the Nano Shrink Ray and the Mysterious Osmotic Effect move through the NanoVerse on a mission to save your patients (s). Battle defective Nanobots, Parasites, Viruses and more. Link: Mission Critical Studios... Flashback: Dr. Nano Nanomedicine Video Game Comes to iPhone...
Michael
Read more [Medgadget]
Study Claims First In-Vivo Gene Delivery
While gene therapy has seemed always just on the verge of being right around the corner, the limitation has always been delivery of the gene. How do you get the new gene to the right cells and activated? An in-vivo mice study in PNAS may take us closer to a usable delivery system. Rui Maeda-Mamiya of the University of Tokyo and others were able to get diabetic mice to increase their insulin levels after delivery of a insulin 2 gene by a water-soluble fullerene. From the study abstract: Water-soluble fullerenes are molecules with great potential for biological use because they can endow unique characteristics of amphipathic property and form a self-assembled structure by chemical modification. Effective gene delivery in vitro with tetra(piperazino)fullerene epoxide (TPFE) and its superiority to Lipofectin have been described in a previous report. For this study, we evaluated the efficacy of in vivo gene delivery by TPFE. Delivery of enhanced green fluorescent protein gene (EGFP) by TPFE on pregnant female ICR mice showed distinct organ selectivity compared with Lipofectin; moreover, higher gene expression by TPFE was found in liver and spleen, but not in the lung. No acute toxicity of TPFE was found for the liver and kidney, although Lipofectin significantly increased liver enzymes and blood urea nitrogen. In fetal tissues, neither TPFE nor Lipofectin induced EGFP gene expression. Delivery of insulin 2 gene to female C57/BL6 mice increased plasma insulin levels and reduced blood glucose concentrations, indicating the potential of TPFE-based gene delivery for clinical application. In conclusion, this study demonstrated effective gene delivery in vivo for the first time using a water-soluble fullerene. PNAS Article Abstract: In vivo gene delivery by cationic tetraamino fullerene Image from PDF of article....
Dan Buckland
Read more [Medgadget]
Envoy Esteem: First Totally Implantable Hearing System Gains FDA Approval
The FDA has given approval for Envoy Medical's Esteem hearing system, the first totally implantable prosthetic for moderate to severe sensorineural hearing loss. The system detects vibrations at the eardrum, processes the signal digitally, then applies physical vibrations directly to the cochlea. Clinical studies showed that 56% had improved hearing with the Envoy Esteem compared to their pre-implant hearing aids. However, 7% experienced facial paralysis and 42% experienced taste disturbance as a result of the surgical implantation of the device. Envoy will follow up with a new study of 120 subjects to further evaluate post-implantation complications and device effectiveness. Video of how the Esteem works... Press release: FDA APPROVES FIRST OF ITS KIND, FULLY IMPLANTABLE (SURGICALLY), INVISIBLE, PROSTHETIC HEARING RESTORATION DEVICE... Product page: Envoy Esteem... Flashbacks: Esteem Totally Implantable Hearing Device Under Consideration for Approval in US; Esteem Totally Implantable Hearing Device On Track for US Approval...
Michael
Read more [Medgadget]
Cell Levitation to Build 3D Matrix Structures
Jokes about needing special glasses aside, Nature Nanotechnology published a letter on March 14, 2010 describing progress in three dimensional cell culture technology from Glauco Souza, et. al. at the Texas M.D. Anderson Cancer Center. According to the research team, prior attempts at 3-D culture have included “protein based gel environments or rotational/agitation-based bioreactors” and yet “broad, practical application of such methods has not been achieved.” The novel method they describe uses magnetic fields to manipulate cells which have endocytosed “gold-hydrogels” which incorporate magnetic iron oxide. Once the cells have taken up the iron in the hydrogel, a magnetic field is applied which levitates the cells, allowing them to grow in a three dimensional architecture as opposed to the standard two dimensional fashion. One benefit of this technology as reported in the letter is the flexibility of the cell culture medium. Current products available use a fixed chemical environment in their scaffolding to support three dimensional growth of cells. Because certain cell populations have specific metabolic requirements which must be met by the culture medium, the fixed chemical environment of existing 3-D culture techniques may preclude specific cell populations from being used. However, because this technology does not rely on a chemical environment, cell lines are not limited by the medium they grow in but rather the ability to take in the iron laced hydrogel. The researchers state the potential applications of their work include “biotechnology, drug discovery, stem cell research, or regenerative medicine.” They go on to say, “Indeed, a potential long-term goal is the possibility of accomplishing the ‘engineering’ of normal tissues or complex organs.” The technology has been licensed to n3D Biosciences out of Houston, Texas. M. D. Anderson press release: 3-D Cell Culture: Making Cells Feel Right at Home Abstract in Nature Nanotechnology: Three-dimensional tissue culture based on magnetic cell levitation Link: n3D Biosciences......
Michael
Read more [Medgadget]
Missouri State Senator Wants Docs to Invade Patients’ Privacy
Meet Tom Dempsey, a threat to the privacy of women in Missouri. State Senator Dempsey recently introduced a bill, SB 792, that would have doctors invade their patients’ privacy and require doctors to try to give patients information that supports his religious agenda even if the patients do not want it. Emphasis added by [...]
Read more [Personal Health Information Privacy]
Information Superhighway Through Your Arm
Scientists at Korea University in Seoul have demonstrated a prototype of a new biomonitoring system that transmits data through the body, replacing wires and minimizing the need for batteries. The device is 300 micrometres thick and in a test, using a metal electrode coated with a flexible silicon-rich polymer, the researchers transmitted data at a rate of 10 megabits per second through a person's arm. The device was tested for skin safety after continuous wearing and the data was transmitted via low-frequency electromagnetic waves through the skin. The technology may have implications for diagnostics, as it can be used to detect electric fluctuations as is currently done by ECG and EEG machines. Read on at New Scientist: Human arm transmits broadband... Abstract in Journal of Micromechanics and Microengineering: Wearable polyimide-PDMS electrodes for intrabody communication...
Michael
Read more [Medgadget]
Unruly Customers
There is a nasty old limerick that begins, "I have no aversions to mergin's with. . ." which is all I can repeat on this family-friendly blog. Well, I do have some aversion to, well, really fear of, AMICAS mergin' with Merge. As a loyal and vocal customer of AMICAS, I need to hear that the AMICAS product line will continue unscathed, which means that the majority of the development team and management will be kept on as well.
No doubt AMICAS never discussed my presence in the Blogosphere with Merge. That might have scuttled the deal right then and there. Just ask GE and Agfa if they enjoy basking in my reflected glory and attention. But its up to the buyer to perform due dilligence and discover these little glitches, and certainly the financiers at Morgan Stanley had the same obligation. I wasn't hiding anywhere, guys!
Merge has returned to viability, if not yet profitability, under the stewardship of Michael W. Ferro, Jr., Chairman and CEO, Merrick Ventures, LLC, owner of Merge, as well as Justin C. Dearborn, CEO of Merge itself. These are smart, successful guys. How smart and successful the lenders at Morgan Stanley are remains to be seen, but one would think they wouldn't release $250 Million without some chance of getting it back with interest. (Of course, this nation just experienced an economic meltdown due to the government forcing lending institutions to give out cash to people that couldn't possibly pay it back, but I digress. . .)
According to DOTmed.com, AMICAS has 250 installations at over 500 facilities. Centricity PACS is installed globally, with over 1000 sites (although none to my knowledge are running the IntegradWeb product purchased several years ago). Fusion RIS/PACS has 200 installs, and Agfa IMPAX has more than 400 sites worldwide. For those who weren't aware, Fusion is the descendant (and I don't know how much it has been changed since then) of the old eMed Matrix PACS.
Historically speaking, Merge bought eFilm in 2002, then RIS Logic in 2003, creating their first integrated RIS/PACS. Meanwhile, Cedara bought eMed in 2004, and then merged with Merge in 2005. From 2006 through 2008, Merge experienced "corporate reorganizations and restatements", and then "returned to profitability" when Merrick invested in it in 2008. This is a reasonable pedegree, not all that different from AMICAS as outlined here. But today, we have Merge with a smaller PACS base and significantly less capitalization buying up its larger competitor courtesy of a very large loan.
Potential PACS buyers, at least those who do their due diligence, often stumble on this blog looking for ideas as to what to buy or what not to buy. I don't have any illusions about my ability to influence anyone, but as the lone radiologist PACS blogger, I do get some minor degree of attention. As such, and as a customer and user of AMICAS PACS since 2004, I have strongly favored and advised its purchase. But, with the current state of affairs, I have to put that ON HOLD for the moment. We MUST hear something about the new owners' intentions toward their new acquisition.
If Mr. Ferro or Mr. Dearborn should feel so inclined to comment, this is what I would like to hear:
I realize this whole merger business was borne of a desire to maximize stock-prices, and as an avowed Capitalist, I must approve. However, as physician using AMICAS PACS, I have to get up on my bully pulpit (which is definately full of bully) and make these statements/requests/demands on behalf of all of us AMICAS customers.
Now we see why the AMICAS Board of Directors failed to include me in their portfolio. Nothing worse than an unruly customer with a blog.
Read more [Dalai's PACS Blog]
EMR Backups
My favorite part of HIMSS is meeting all sorts of interesting people. One of those people I met was Lyndsey Coates from Nuesoft. I have a soft spot in my heart for Nuesoft since they were the company that trained me on my first EMR. I still remember the 3 day intense training in their office. Lyndsey and I had interacted a few times before the conference and so it was nice to meet her in person. It was just too bad that we didn’t get to spend more time together. What does this have to do with EMR backups? Well, Lyndsey and I didn’t have much time together at the conference, but she sent me a nice bloggers “love note” in the form of a blog post about offsite EMR backup systems after meeting me at the conference. She even sent me a friendly tweet to let me know about the post. I was a little busy with HIMSS and all, but I’m always happy to share in a little blog sparring. So, Lyndsey, here we go. I’m really glad to hear you respect my opinion, but I’m a little surprised that you didn’t like my post about offsite EMR backup services. I guess I could have imagined that a SaaS EMR vendor might have a different view. In fact, you make a nice case in your blog post about the challenges of backup with the client server model. Definitely a number of good points for doctors to consider when selecting their EMR. However, somehow your post left out some of the problems related to backups with a SaaS EMR. No worries though, I’ll be happy to share;-) First and foremost, I can’t believe you think that doctors will trust an EMR vendor to back up their EMR appropriately. I mean seriously, we’re talking about my whole clinical practice stored on your servers and trusting that your IT staff are doing my backups? I don’t think so. I barely trust my own staff to do backups, so why would I trust my EMR vendor’s staff to do something as important as the backups of my EMR? No, I’m definitely not trusting you and your IT staff to backup my EMR. Maybe there are a lot of doctors that don’t do backups properly, but there are a lot of large vendors that don’t do backups properly either. Yes, even the all powerful Google lost some data because they didn’t have the right backups. Plus, if you’re doing my backups that means that you establish the policy and time frame that the backups are done. If I do them in house, I get to schedule the backups, verify the backups and see the reports and logs about when backups are done. I get to choose when and how often those backups are done. With you, I just have to hope that you’re doing them. Plus, there’s just something that doesn’t feel right about you having the backup of all my data. Maybe you don’t remember that the data stored in the EMR is my life. Not my literal life, but the life of my practice. Maybe you feel comfortable with my life being stored in your redundant data centers across redundant servers who mirror the data and all sorts of other cool backup processes. Personally, I feel comfortable knowing I have a backup of my life in my office with me. I can see it, touch it, pet it and know that it’s safe in my loving arms. Finally, let’s not call out my previous post about Offsite Backup Service for EMR for “missing the mark a bit.” While SaaS EMR are doing very well, there’s still a VERY large number of people who will select a client server EMR. Better to help them get their client server backup services right than to just tell them that they should have bought a SaaS EMR. Plus, maybe Nuesoft and other SaaS based EHR should consider partnering with one of these offsite backup solutions. I imagine a lot of doctors would love to have their SaaS EHR backed up to an offsite backup provider like the ones I mentioned in that post. Basically, a location that the doctor can access and control. Could be an interesting service to offer your clients. Your turn Lyndsey! P.S. I personally don’t care either way. I think that the client server or SaaS model are legitimate EMR solutions. Long term SaaS EMR are likely to win the day, but that’s still a long ways away. I do enjoy playing devil’s advocate though. Related posts:
Read more [EMR and HIPAA Blog]
Virtobot Performs Virtual Autopsies
Virtobot is the name of a forensic robot used at the University of Bern's Institute of Forensic Medicine to perform virtual autopsies. In the futuristic Virtopsy laboratory, the robot scans the contours and texture of the human body by projecting light bars on it and acquiring high definition images. These data are combined with the CT images acquired by the scanner in the same room. A three dimensional image of the body is then reconstructed that can be used during forensic examinations and be preserved as long as necessary. Additionally, the robot can also perform CT guided biopsies. The US forces have already installed a Virtopsy laboratory at Dover Air Force Base in Delaware to assess the cause of death of soldiers sent back from Iraq and Afghanistan. Video of the Virtobot in action: Press release: Digital future heralded for forensic medicine... The Virtopsy Project on Youtube......
Wouter Stomp
Read more [Medgadget]
Massachusetts health care cost trends hearings yield data, stir heated debate
Tuesday's Boston Globe reported that Harvard Pilgrim Health Care (one of the Big Three not-for-profit insurers here) released hospital payment data confirming what the AG's office had previously reported (and what has been widely surmised or known for years) -- namely, that certain hospitals get paid substantially more for the same services and results as are provided by other hospitals, based on their market power -- whether that is based on "brand-name" status of certain downtown teaching hospitals, or local geographic market power of relatively isolated providers. The AG's final report (press release with link to report) confirms this bottom line. Update 3/19/10: See Paul Levy's post on the hearings at Running a Hospital. Local iconoclasts Alan Sager and Deborah Socolar, Directors of the Health Reform Program at the Boston University School of Public Health presented their health care cost trends report as well, and see the Commonwealth as heading over a cliff. (The graphic reproduced above is drawn from this report.) The Massachusetts Hospital Association questioned the conclusions they've drawn from the data presented. The former CEO of Harvard Pilgrim, Charlie Baker, is Gov. Patrick's GOP challenger; as I've noted before, Patrick is seeking to re-regulate rates (while Charlie was instrumental in their deregulation). Tim Cahill, running as an independent, has attacked the Massachusetts health reform law; the Globe, in an editorial, castigated him for his invective, calling it "irresponsible demagoguery" in the face of some rather serious problems: These nightmarish projections at yesterday’s UMass hearing came from Len Nichols, health care economist at George Mason University. “We can’t afford business as usual,’’ he warned. Let's hope that the Commonwealth can have the space to effectively work out cost control -- the second leg of the proverbial three-legged stool of health care reform. In any event, health wonks around these parts will be glued to their screens Thursday
and Friday, as these hearings are being livestreamed. Folks elsewhere in the country may also find this instructive, given the close relationship between the Massachusetts approach and the approach to health insurance reform found in the Congressional bills now under consideration. David Harlow
The Massachusetts Division of Health Care Finance and Policy and the Attorney General's Office are holding three days of hearings this week on health care cost trends. You may wish to get up to speed by taking a look at the HealthBlawger's earlier review of preliminary reports on Massachusetts health care cost trends and positioning by key participants. There is a comprehensive collection of preliminary reports and testimony on the Commonwealth's website.
The Harlow Group LLC
Health Care Law and Consulting
Read more [HealthBlawg - David Harlow's Health Care Law Blog]
Peter Neumann, Director, Tufts Center for the Evaluation of Value and Risk in Health, speaks with David Harlow about the role of cost-effectiveness research in health care policy
The national debate on health care reform is currently focused on health insurance reform -- coverage, one of the proverbial three legs of the health care reform stool: coverage, cost and quality. In order to bend the cost curve -- no matter what the approach to health care reform: be it federal legislation, state initiatives, federal pilots and demonstration projects, and/or private sector initiatives -- most would agree that we need a rational approach to cost-effectiveness research, or comparative effectiveness research that we can all rely upon. Anyone who embarks on a search for such an approach will soon find Peter Neumann's Center for the Evaluation of Value and Risk in Health at the Tufts University Medical Center and the CEVR's Cost-Effectiveness Analysis Registry. I spoke with Peter this week about the use of "quality-adjusted life years," or QALYs, as a tool in standardizing the measurement of benefit derived from different interventions (be they medical, surgical, pharmaceutical), so that results of cost-effectiveness research used in the health care policymaking sphere can be compared, apples-to-apples, when we need to make tough decisions about paying for certain interventions and not for others. The Registry may aid in making such choices, since its purpose is to provide standardized summaries of all studies using QALYs to quantify benefits of interventions, allowing for easier comparisons to be made across interventions and across conditions. The audio file of my interview with Peter Neumann (about 25 minutes long) is available for download/podcast. A full transcript is at the end of this post (and in the linked Peter Neumann, Tufts CEVR Director, HealthBlawg Interview transcript). We also touched on the ways in which cost-effectiveness research may be used by clinicians and policymakers in their decisionmaking as one of an array of factors; American exceptionalism; communications failures (as in the case of the mammography guidelines released a few months ago); and the prospects for cost-effectiveness research to inform development of clinical practice guidelines in the future. HealthBlawg :: David Harlow’s Health Care Law Blog
The Harlow Group LLC
Health Care Law and Consulting
Director, Center for the Evaluation of Value and Risk in Health
Tufts University Medical Center
March 16, 2010
David Harlow: This is David Harlow at HealthBlawg, and I have with me today Dr. Peter Neumann, who is the Director of the Center for the Evaluation of Value and Risk in Health at Tufts University Medical Center here in Boston. He is also a Professor of Medicine at the Tufts University School of Medicine. Hello, Peter, and thank you for joining us.
Peter Neumann: Thank you, David.
David Harlow: So I would like to ask if you could, just for starters, introduce us a little bit to the work of the Center for the Evaluation of Value and Risk in Health.
Peter Neumann: Sure, well thanks for inviting me; I’m pleased to be here. Our Center focuses on a variety of health economics issues and essentially we are a group of economists and other researchers who are trying to understand how we can better spend our health care dollars, and we do that by measuring the cost-effectiveness of the value of different health care interventions. So we’re looking at pharmaceuticals, devices, procedures, public health programs - a variety of different strategies in health and medicine and trying to understand, in a sense, the health gains for the dollars that we spend in different areas, and how we can deliver health care and to improve health most efficiently.
David Harlow: Yes, so you work with private industry as well as with governments, I understand, and I’m wondering whether you see an openness to this sort of approach in the midst of the national debate on health care reform here in the United States; or whether there’s a different sort of openness or resistance to the quantification of these matters in the public debate here versus elsewhere in the world or in other circumstances.
Peter Neumann: Right, we do work with diverse groups; so we work on government grants, we work with foundation grants and we do work with private industry as well. So I think everyone recognizes we need to deliver care more efficiently and everyone recognizes that we have a cost problem and that formal analysis likely will help us understand what we are getting from what we are spending. That said there is a lot of sensitivity around using cost-effectiveness analysis openly. People are worried that it will result in rationing of care to people who need care, will result in denying care in ways that are unfair and so forth. So even while we recognize our cost problems, there is great concern that these techniques would be used inappropriately.
I think there’s more openness to using these techniques, broadly speaking, outside the US than inside the US. No one even overseas likes to deny care or ration or use cost- effectiveness analysis explicitly, perhaps. But I think there’s a greater willingness in many countries - certainly in many western European countries, in Canada, Australia, even countries in Asia – to set limits using cost-effectiveness information to inform health care choices, and that hasn’t been the case in the US to a large extent.
David Harlow: Yes, now one of the terms used in some of these analysis, including some of the analysis that you’ve written and participated in, is the term ‘the quality-adjusted life year’ which I think raises a lot of red flags for US-based listeners and readers; and I’m wondering whether you can help us understand how that term is used. What does that measure mean and how is it used explicitly or implicitly in the sorts of analysis that you and others are doing in this field?
Peter Neumann: Sure, so the quality-adjusted life year, or QALY, is a health metric, it’s a measure of health that combines morbidity and mortality into a single number. We often think about life expectancy as a metric that sort of helps us think about gains in health and we talk about people’s life expectancy, we might even talk about life expectancy gains with a new cancer therapy - say a new cancer drug may come along, and on average it increases one’s life expectancy for those with cancer say by one year.
All that a quality-adjusted life year is doing is adjusting that year of life gained with some information about the amount of impairment or disability lived in that life year. So you could imagine someone might gain a life year with cancer but they live that life in very poor health, so we would weight that life year by some amount. They would only get, say, a half of a quality-adjusted life year gained. So the quality has been…
David Harlow: Let me interrupt you for a moment; if I can like to interrupt you . . . Well, many patients or families would say well, I am happy to make that sort of assessment on my own, let me be the judge…
Peter Neumann: Sure.
David Harlow: Of whether a year in pain is worth half a year.
Peter Neumann: Sure.
David Harlow: Don’t let an economist make this decision for me.
Peter Neumann: Sure, there’s a lot of pushback to economists or - even worse - bureaucrats making these decisions that patients would like, and feel they should make on their own. So a QALY is really a population-based metric, in a way, it’s an average of sorts, averaging across different people in the population and we do that in all sorts of ways in health care. We average results from clinical trials into a single number, a new drug improves quality of life by so much and a new drug, a new program improves life expectancy by so much; and those are population-based metrics as well and they’re used as guides to clinical care, and maybe to policy.
So a QALY is not doing anything really that different. I think one of the red flags that your question suggests that is a little bit different as well: My being in pain is very different than my neighbor’s being in pain. I maybe don’t tolerate pain as well, so I have a different number and while that’s probably true or at least true that people all have different preferences around health states – again, all the QALY is trying to do is give a guide to roughly amount of life lived and the quality of that life lived.
And so the other thing I suppose I would add is, a physician treating a patient can look at a QALY and make his or her own informed decision along with the patient about whether it’s applicable for them in their particular circumstance.
But I think as your question rightly highlights, it is with some controversy. And people feel often that QALYs are not capturing what they care about, that’s another criticism of the QALY: that people may care deeply about aspects that are not captured by quality-adjusted life years gained. For example, we might want to give priority to certain populations, whether or not it’s the QALY-maximizing thing to do, we might want to give priority to vulnerable populations or children or people with rare diseases or people with cancer and people with - and on and on. Whether or not the QALY-maximizing strategy would lead us there and I think that’s a very real concern and again all the QALY is doing is giving a benchmark or a common metric to help us understand the gains for the spends.
David Harlow: Yes. So it’s a metric. And what you are saying is that a policymaker could add other adjusting factors when translating a result that’s in terms of QALYs into a policy decision.
Peter Neumann: Exactly. And the economist would say: well, resources are limited, whether we like that or not, we can’t do everything we want for everyone who is in need of care and we do make decisions and those decisions have implications. The QALY is simply a guide to helping us make those decisions more fairly and consistently and perhaps rationally.
David Harlow: You’ve written or spoken in the past about the notion of American exceptionalism and that’s a notion that a lot of folks have been speaking about in connection with the health care reform debate in recent months. My question to you is whether there is anything we can learn from the ways in which other countries in the world have resolved or attempted to resolve these issues of allocation of scarce resources in health care? What can we learn from the way this has been addressed elsewhere in the world? Is there a particular country or two that you think has addressed this particularly well?
Peter Neumann: Right, so there is this theme of American exceptionalism that is much broader than just in health care, but the basic idea, oversimplified somewhat, is that because of our unique history and culture, our strong inclinations towards personal economic freedom and the institutions we’ve set up that make it difficult to enact major change, and the culture’s sort of broad mistrust of government and big corporations that makes it very hard for us to enact policies, universal health care, it’s very hard for us to use cost-effectiveness analysis, and so forth.
So other countries also have their own unique history and systems and culture, and have addressed this in ways that I think offers some lessons to us. They’ve created institutions in places - the UK is a good example, Canada is another - where they have policy experts, often including stakeholders, citizens’ councils, physician groups and others, patient advocates perhaps, who are collectively trying to make these difficult decisions and using economic evaluation, cost-effectiveness analysis, to help make those decisions; and in many cases not covering new technologies that are very expensive but have small marginal gains. So the UK maybe most famously has an institute called the National Institute of Health and Clinical Excellence that sifts through the data, looks at the economics of new treatments and then decides whether or not to cover. And in some cases at least decides not to pay for new very expensive technologies that offer marginal benefits.
David Harlow: Do you think that there would be a change in approach or a change in decisionmaking about what should be covered, what should not be covered, if there were a change in the basic approach to reimbursement for health care services in this country? Would a change in those incentives drive a change in behavior of providers?
Peter Neumann: Well I’m a strong believer that it would. I think part of the issue that we’ve been talking about is the information itself and to what extent do we use that information in decisions. Another issue we haven’t to this point talked about is the incentives in the system, and I think the information would have a much bigger impact in an environment with different incentives. So if providers were under bundling arrangements where you have a global payment that follows a patient with a particular disease for example, particular diagnosis, I think the incentives change in ways that makes this information more relevant and more powerful. And there are other ways to change incentives to also make this information more relevant - it could be salaried physicians, it could be changing incentives to do more and getting paid more, it could be incentives that are different for patients where they face more cost sharing.
Now changing incentives in all those ways has some potential downsides too, of course, but I think in an environment where we really have a cost crisis, I think we are going to see changes in incentives and behavior will change accordingly. And I think this information that we’ve been talking about, cost-effectiveness analysis, may have a more important role in ways it doesn’t have today.
David Harlow: Speaking of incentives, on everybody’s mind these days are the incentives for the propagation of electronic health records systems in this country. I’m wondering whether you see an opportunity there for gathering of more data in an effective way through the deployment of electronic health records systems that would help inform some of the decisions that we are talking about.
Peter Neumann: Yeah, absolutely. I think giving people incentives is being widely discussed and maybe we are seeing some policies now to use electronic medical records should have an impact that in turn will generate lots of data with clinical detail we don’t have now; and that kind of information can feed into analyses that can help us better understand the impact of different treatment strategies - both safety and efficacy and cost- effectiveness.
So I think there is perhaps a data issue, data problem, infrastructure problem that exists today where I think we are not capturing the kind of information that would be possible if encounters led to more systematic data capture. So I think that would be an important part of moving forward.
David Harlow: Okay. Now one of the projects that I understand you’ve been working on - that your Center has been working on for a while - is a registry of cost-effectiveness studies, Cost-Effectiveness Analysis Registry and I wonder if you could speak a little about that, explain what that is, how you use it in your work.
Peter Neumann: Sure, it’s the Tufts Medical Center Cost-Effectiveness Analysis Registry which we refer to as the CEA registry. And it's essentially a database of published cost-effectiveness analyses, and these are studies that have appeared in the peer-reviewed Medline literature that my group, there is a formal protocol for the collection of data from each of these published studies.
We collect something like 35 or so variables on each cost-effectiveness analysis. We have two readers independently reading each study and then coming and meeting in consensus; their consensus meeting to enter data into a database. We enter data on the cost-effectiveness ratios that are produced by these studies as well as a lot of detail on how the studies were conducted. So with an online searchable database, and I would invite all of your listeners and readers to go on the site if they are interested it's www.cearegistry.org and you can plug in a word or phrase or an author’s name and so forth or type of intervention.
So for example if you were interested in what is cost-effective in the area of multiple sclerosis you can look and plug that term into the database and you’ll find published studies on the cost-effectiveness of interventions for MS and similarly for any other disease that you’d like.
I should emphasize all of these studies are in the form of cost per QALY studies so that is the currency or benchmark that we use. The great strength of that is that the results are comparable so you can compare a cost per QALY in a study on depression, to a study on cancer to a study on I don’t know some kind of new diagnostic technique to detect I don’t know, I’m making it up, heart disease.
So there’s lots more I can say about this database but we’ve always viewed it as a public resource and we plan to expand upon it in the future, and the goal of this exercise is really to try to understand society’s best opportunities for improving health efficiently. So we’ll keep it going in the future and again I invite everyone in and we’d love feedback if anyone has any.
David Harlow: Terrific. What I’d like to ask a little bit more about there is - you’ve mentioned a moment ago about the notion of using QALYs as a standardized measure so you could look at issues across different diseases or treatments and I’m wondering, what would you be looking at exactly if you’re comparing effectiveness between a cardiac issue and a neuromuscular issue? What would be the outcome of that comparison?
Peter Neumann: Right, so the idea is we have limited resources to spend on health and we need some common measure that would allow us to say, “well, the money we have to improve health is better spent over here in a certain area, than it would be spent in a different area” so the way we standardize everything is through these cost per QALY ratios.
So for example if you have some kind of surgery for cardiac care a study might - someone might do a study and say the net cost per QALY gained for that type of surgery is say $10,000 per QALY and the neuromuscular condition let’s say an expensive new drug and the cost per QALY ratio in the study someone has reported is $200,000 per QALY. So the idea is if you’re trying to improve health it's much more efficient to spend that money on the cardiac care than it is on the neuromuscular drug in that case.
And while it's difficult to make direct comparisons across very diverse treatments this gives us a way of measuring value for different uses of resources to improve health. And what some countries are doing is saying we are not going to pay for the very expensive strategies, the $200,000 example, and we will pay for the less expensive more efficient better value strategies, the $10,000 for example.
David Harlow: If you had a crystal ball how would you predict this sort of information playing out into coverage decisions and policy decisions in this country?
Peter Neumann: Well, I think there will continue to be a lot of concern and sensitivity around doing cost-effectiveness analyses openly. I think it’s still fraught with a lot of political problems and mistrust and so forth. However, I think that we will slowly but steadily begin to use more of this information and we are beginning to see it - even in Medicare we are beginning to see it on the prevention side. So how frequently you screen for cancer is really an issue of the clinical and the cost-effectiveness information.
So you know at the extreme we could screen for cancer very frequently - every month - or we could screen much less frequently - every ten years - and what the right level of frequency is determined by the clinical outcomes of screening, it’s determined by false positive rates and by maybe some safety issue that would result from false positives. But it's also a cost issue and I think we will have cost-effectiveness information informing decisions like that; not only frequency of screening but we will have it likely for which subgroups get which types of prevention. Perhaps immunization schedules in the future will be informed by this and maybe even in certain cases, and I think this will come, treatment guidelines; failing cheaper therapies first before you get to the expensive one.
That’s a decision that can be informed by cost-effectiveness analysis. Even if you take the more expensive ones first and it gives you a little bit more clinical benefit, guidelines increasingly will dictate that patients try the cheaper drugs first or the cheaper treatments first and then get to the more expensive ones only if they can’t tolerate or they fail the others. And again I think cost-effectiveness analysis in the public sector and the private sector will inform those kinds of decisions.
David Harlow: Yes, well it certainly seems to make a lot of sense. The question is always how it is communicated. We’ve seen some stellar communications failures in the context of the mammography guidelines in recent months and changes in the way that’s been explained following a public relations disaster…
Peter Neumann: You’re right.
David Harlow: And it remains to be seen how those will actually be implemented by payors.
Peter Neumann: Yeah I think you’re absolutely right and the mammography episode shows how challenging this is going to be - but even there, there are limited resources, there are complex cost-risk-benefit trade-offs and we will see how it plays out. But I would argue even there, cost-effectiveness analysis could help us think through those issues, but it certainly will not be easy.
David Harlow: Yes, well, thank you very much. I have been speaking with Dr. Peter Neumann, Director of the Center for the Evaluation of Value and Risk in Health, Tufts University Medical Center. This is David Harlow on HealthBlawg, and thank you for listening.
Read more [HealthBlawg - David Harlow's Health Care Law Blog]
FDA Studying Approval of Drug Cocktails for Life-Threatening Diseases
In a major policy shift, the FDA is opening the door for the future approval of drug cocktails to treat life-threatening diseases such as tuberculosis in a more effective way (see: FDA Is Easing Way for Drug Cocktails; subscription required). Below is an excerpt from the article: This article mentions regulatory science, a term with which I was not familiar. It turns out that academic degrees are now being offered in this field. I am sure such graduates will be cordially welcomed by both the FDA and by the pharmaceutical companies on a much larger scale. One of the core competencies of such companies is the ability to maneuver through this complex bureaucratic pathway. Less time and effort to achieve drug approval equals less cost for them in bringing a drug to market. Knowing how difficult it is to gain FDA approval for new drugs, I can only imagine how complex a process it will be to study new compounds that are administered in combination with other agents. It's a bit of an understatement to say, as above: testing drugs together can make it more difficult to tease out which drugs or drug interactions cause certain side effects. I can't resist pointing out the analogy of between multi-drug cocktails and the development of panels of biomarkers interpreted by a computer algorithm that the FDA refers to as IVDMIAs. The attempt by the FDA to regulate them has been challenging for the agency. The second draft version of guidance dates back to July, 2007. In my mind, we are now facing a future with both therapeutic cocktails and diagnostic cocktails. This perhaps is a reflection of modern life and modern medicine whereby a single drug or a single biomarker no longer suffices. And the FDA is being forced to operate as a regulatory agency in this new environment. One of the gnarly issues associated with IVDMIAs has been proving diagnostic efficacy. Both efficacy and safety will be even a greater challenge on the drug side of this equation.
Read more [Lab Soft News]
Breaches of patients’ data raise questions on security methods
In the aftermath of the recent Wake Forest University Baptist Medical Center breach, John Hinton of the Winston-Salem Journal has this piece on hospitals allowing employees to remove patient data from their facilities and whether patients know that that might happen.
Read more [Personal Health Information Privacy]
Meaningful use for nursing. Six themes regarding the definition for meaningful use.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 12-30-2009 at 04:26 AM
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Narrowing PubMed searches to nursing-related articles.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 12-18-2009 at 04:09 AM
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The new fundamentals in nursing: introducing beginning quality and safety education for nurses' comp
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 02-24-2010 at 04:10 AM
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Health information literacy: hardwiring behavior through multilevels of instruction and application.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 01-15-2010 at 04:42 AM
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Implementation of standardized nomenclature in the electronic medical record.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 01-15-2010 at 04:42 AM
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[Promoting nursing competitiveness: introduction to the digital divide.]
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 02-04-2010 at 04:08 AM
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Adoption of a PDA-based home hospice care system for cancer patients.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 01-29-2010 at 04:45 AM
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Technologies enable seniors to age in place.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 03-18-2010 at 04:43 AM
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IT Sales Executive - VeriScan
Forum: Recruiter Posted Informatics Jobs
Posted By: carolfelsenthal
Post Time: 01-08-2010 at 10:51 AM
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Clinical practice corner: health information technology.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 02-03-2010 at 04:34 AM
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Cutting the cord. CIOs are leveraging wireless technologies to help nurses deliver patient care safe
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 03-03-2010 at 04:26 AM
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The Alliance for Nursing Informatics: A History.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 02-26-2010 at 04:16 AM
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Manager of Nursing Informatics - iMethods - Jacksonville, FL
Forum: Recruiter Posted Informatics Jobs
Posted By: cgambino
Post Time: 01-21-2010 at 03:32 PM
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On the horizon: dialogues for the nursing academy.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 01-27-2010 at 04:24 AM
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A quantitative analysis of the impact of a computerised information system on nurses' clinical pract
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 01-27-2010 at 04:24 AM
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Getting IT together.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 01-27-2010 at 04:24 AM
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Evaluating your information system implementation.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 01-13-2010 at 04:18 AM
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[Standardized nursing language: the bedrock of computerized nursing records]
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 01-13-2010 at 04:18 AM
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Collaborating to optimize nursing students' agency information technology use.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 01-29-2010 at 04:45 AM
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Instance testing of the family history ontology.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 01-09-2010 at 04:35 AM
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Recording practices and satisfaction of hemophiliac patients using two different data entry systems.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 01-29-2010 at 04:45 AM
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Description of inpatient medication management using cognitive work analysis.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 01-29-2010 at 04:45 AM
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Applying PNDS to a standardized framework.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 01-29-2010 at 04:45 AM
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IT Sales Executive - VeriScan - Denver, Colorado, 80012
Forum: Recruiter Posted Informatics Jobs
Posted By: carolfelsenthal
Post Time: 01-08-2010 at 10:58 AM
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IT Sales Executive - VeriScan - Atlanta, Georgia, 30301
Forum: Recruiter Posted Informatics Jobs
Posted By: carolfelsenthal
Post Time: 01-08-2010 at 11:03 AM
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A state profile of IT sophistication in nursing homes.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 01-09-2010 at 04:35 AM
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Korean nurses' experiences: the Influence of NNN (NANDA-I, NIC, NOC) terminologies on nursing workfl
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 01-09-2010 at 04:35 AM
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Identifying logical clinical context clusters in nursing orders for the purpose of information retri
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 01-09-2010 at 04:35 AM
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Representing nursing assessment documentation with ICNP.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 01-09-2010 at 04:35 AM
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From the Editor-in-Chief.
Forum: Nursing Informatics Journal Articles
Posted By: Nursing Informatics News
Post Time: 02-18-2010 at 04:05 AM
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Retinal Implant First Results from Human Trial
Retinal Implant AG from Reutlingen, Germany has announced the results of the first human trial of its subretinal implant. Eleven patients who lost their sight due to retinitis pigmentosa received the implant through surgical transchoroidal implantation. Energy was delivered to the implant via a retroauricular plug. Implantation was successful in all patients without any adverse events. From the press release: “I first noticed my eyesight was impaired at 16, and over a period of 16-17 years, my condition deteriorated to complete blindness,” said the 11th patient, a 45 year-old Finland-based male. “I knew there was a chance the implant wouldn’t enable me to see anything, but I was willing to participate in the research with the hope I would regain some sight. When the microchip was turned on, I immediately was able to distinguish light from dark and see outlines of objects. As I got used to the implant, my vision improved dramatically. I was able to form letters into words, even correcting the spelling of my name. I recognized foreign objects such as a banana and could distinguish between a fork, knife and spoon. Most impressively, I could recognize the outlines of people and differentiate heights and arm movements from 20 feet away.” The implant was removed according to protocol after one or three months, but one study participant was apparently so happy with it that he refused explantation and now has been carrying the implant for four years. The study findings will be presented on May 3th on the annual meeting of the Association for Research in Vision and Ophthalmology in Fort Lauderdale, Florida. Press release: Subretinal Implant Restores Unprecedented Level of Vision to Blind Patients... Presentation abstract: Subretinal Visual Prosthetic Devices in Blind Patients. Modifications in Transchoroidal Surgery and Long Term Follow Up in the First 12 Patients...
Wouter Stomp
Read more [Medgadget]
Medtronic's MiniMed Paradigm REAL-Time Revel System Receives FDA Approval
Medtronic has received FDA approval for its integrated diabetes management system called MiniMed Paradigm REAL-Time Revel System. The system combines insulin pump therapy, continuous glucose monitoring and diabetes therapy management software. It features predictive alerts which signal trends in blood glucose levels notifying patients to take preventive measures. For maximal comfort it can be combined with the Medtronic wireless continuous glucose monitoring system and measurements can be uploaded to the online Carelink personal management software. The system is made available immediately in five different colors. Press release: Medtronic Receives FDA Approval for Industry's Most Advanced Integrated System for Diabetes Management ... Product page: MiniMed Paradigm® Revel™ Insulin Pump ... NOTE: We would like to welcome Dr. Wouter Stomp to Medgadget editorial board. He is an MD from the Netherlands, currently working on PhD in radiology. This is his first post....
Wouter Stomp
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